AUTOMATING SUBUNIT MAB ATTRIBUTE SCREENING FOR IN-PROCESS MONITORING OF AN AUTOMATED HIGH-THROUGHPUT MULTI-PARALLEL BIOREACTOR

Postery | 2023 | Waters | ASMSInstrumentace

LC/TOF, LC/HRMS, LC/MS

Zaměření

Farmaceutická analýza

Výrobce

Waters

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Souhrn

Význam tématu

Automatizovana analyza subjednotek monoklonalnich protilatek poskytuje rychle ziskani klicovych kvalitativnich atributu behem vyroby. Tento pristup umoznuje optimalizaci bioprodukcniho procesu a zlepseni konzistence vysledneho produktu.

Cile a prehled studie

Cilem studie bylo vyvinout plne automatizovany workflow pro odber a pripravu vzorku z vice bioreaktoru a naslednou LC MS analyzu subjednotek. Studie zahrnovala sledovani ruznych kombinaci media feedu a hustoty inokula v ramci patek paralelniho bioreaktoroveho systemu Ambr 250.

Pouzita metodika a instrumentace

Workflow se sklada z nasledujicich kroku:

Odběr vzorku z paralelniho bioreaktoru Ambr 250 High Throughput
Protein A purifikace a digesce enzymem FabRICATOR pro ziskani lehkeho retezce LC, fragmentu Fd prime a Fc fragmentu
Redukce DTT a automatizovana priprava vzorku pomoci pipetovaciho robotu Andrew plus a modulu Extraction plus
Separace a analyza LC MS s BioAccord systemem a BioResolve RP mAb Polyphenyl kolonou pri 60°C
Data spojena a zpracovana v software waters_connect Intact Mass Application

Hlavni vysledky a diskuse

Doba automatizovane pripravy 48 vzorku trva mene nez tri hodiny. Byly sledovany nasledujici atributy:

Glykovani lehkeho retezce LC a fragmentu Fd prime
Glykosylace Fc zahrnujici fukosylaci, afukosylaci, mannose Man5 a modifikaci terminalniho lyzinu
Sialylacni profily ruznych bioreaktoru

Rozdily mezi podminkami media a feedu vedly k odlisnym profilum glykanu a urovni C term modifikaci. Media typu B vykazovala zvysene hladiny terminalniho lyzinu a sialylace. Glykany se vyvijely v prubehu dni 4 az 12.

Prinose a prakticke vyuziti metody

Zvyseni propustnosti a reprodukovatelnosti pri vysledne analyze
Realne casove sledovani procesu s okamzitou zpetnou vazbou pro rozhodovani
Umozneni rychle optimalizace bioreaktoru a procesnich parametru

Budouci trendy a moznosti vyuziti

Integrace s dalsimi analytickymi technologiemi pro komplexni sledovani kvality
Rozsireni workflow na jine typy biologickych molekul
Pouziti strojoveho uceni pro predikci kvality a proaktivni upravy procesu

Zaver

Plne automatizovany workflow pro subjednotkovou analyzu monoklonalnich protilatek prokázal vysokou efektivitu a spolehlivost. Metoda poskytuje rychle a komplexni informace o klicovych kvalitativnich atributech behem vyvoje procesu.

Reference

Koza Stephan M Hanna Caitlin Jiang Robert Yu Ying Qing Automated HT Analytical Scale Monoclonal Antibody Purification Using Production Scale Protein A Affinity Chromatography Resin Waters Appnote 720007861 2023

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